Efficacy and safety of Cefadroxil for chronic myelogenous leukemia

JRCT ID: jRCTs061180073

Registered date:20/03/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Chronic myelogenous leukemia
• Date of first enrollment: 20/06/2017
• Target sample size: 20
• Study type: Interventional
• Intervention(s): Patients received CDX (at an oral dose of 1500 mg per day) with TKI which they have already taken (1 course). This regimen is repeated three times.

Outcome(s)

• Primary Outcome: Overall response rate
• Secondary Outcome: Safety, pharmacokinetics

Key inclusion & exclusion criteria

• Age minimum: more than 20 years old
• Age maximum: Not applicable
• Gender: Both

Include criteria

(1) CML-CP achieves MR 3.0, but not MR 4.0
(eligible fisrt and later second chronic phase
(2) After acheivement of MR 4.0 and stopped TKI, molecular relapse over MR 3.0 is observed.
(3) ECOG performance status 0-1
(4) more than 20 years old
(5) outpatient
(6) Patients from whom informed consent has been obtained using documents.

Exclude criteria

(1) History of shock against CDX
(2) Infectious mononucleosis
(3) Hypersensitivity against cephalosporin and penicillin antimicrobial agents
(4) Renal insufficiency (CCr;less than 50ml/min.)
(5) Difficulty of oral intake and receiving the parental nutrition
(6) History of receiving stem cell transplantation
(7) Cardiac dysfunction (necessary of medication for arrhythmia, ischemic cardiac disease, heart failure and cardiomyopathy)
(8) Pregnancy, nursing or possibly pregnant women
(9) Attempt to get the child and no will of contraception
(10) Patients received cephalosporin within twelve weeks ago before this trial
(11) Patients participated other trail study and took trial drugs.
(12) No indication for this study as judged by physicians in charge

Related Information

• Primary Sponsor: ICHINOHE Tatsuo
• Secondary Sponsor: NAKA Kazuhito
• Secondary ID(s): UMIN000027904